Let's now look at one of the approaches about the types of software changes, As it appears in an organization as serious as the FDA (Federal Drug Administration) of the United States to be able to deal with these problems.

In order to understand first I clarify what a 510 (k) is:

A 510 (K) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent to a legally marketed device (section 513 (i) (1) ( A) FD&C Act) which is not subject to premarket approval.

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